MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	PV-20-50-HELIX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding three different concerto coils that had separate issues during a procedure.The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (pavm).Patient's blood flow was normal; vessel tortuosity was moderate.It was reported that all devices were prepared as indicated in the instructions for use (ifu).Continuous flush was administered during the procedure.During the procedure concerto coil (pv-20-50-helix, lot: d036397) experienced friction during delivery and the pushwire proximal segment was bent.The coil was removed and replaced to continue the procedure.Another coil (pv-18-40-helix, lot: d012376) could not be detached.Four attempts were made to detach the coil with the instant detacher (id).A second id was tried, and the coil still did not detach after three attempts with the second id.It was noted that there was no problem with the id's.The doctor tried once to detach the coil manually without success so the coil was also removed and replaced to continue the procedure.A third coil used during the procedure (pv-20-50-helix, lot: d036397) experienced friction during delivery and separated or detached prematurely.It was noted that the physician repositioned the coil twice but did not rotate the delivery pusher and had not attempted to detach the coil.The pushwire was not bent or broken.The coil was implanted at the intended location and no additional surgical or medical intervention was required.There was no harm or injury to the patient associated with the reported events.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that for coils pv-20-50-helix, lot: d036397 and pv-20-50-helix, lot: d036397, resistance was in the distal section.The coils came out of the introducer sheath with resistance.After removal there was kink/damage at the distal part of the pushwire of the catheter.The catheter was merit¿s taper microcatheter.Regarding coil pv-18-40-helix, lot: d012 376, no pushwire damage was observed after removal from the patient.The information is confirmed by the physician.
Additional Manufacturer Narrative
Product analysis as found condition: two concerto devices were returned for analysis within a shipping box, a sealed plastic biohazard pouch, within a plastic pouch.It is not possible to determine which concerto belongs to which pli; therefore, they will be analyzed together (pli-10 or pli-30).The first concerto device introducer sheath was found to be applied incorrectly with the wavelock facing towards the distal tip of the implant coil.The actuator interface was found to be secure within the pushwire coupler tube.The break indicator was found to be undamaged.The pushwire was found to be bent at ~60.9cm and bent at ~66.7cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath at ~91.8cm and bent at ~55.7cm from the distal end.The concerto implant coil was returned attached to the pushwire detach element; however, the implant coil was found to be damaged within the proximal segment of the introducer sheath (wavelock).No other anomalies were observed.During testing, the first concerto implant coil was unable to advance outside of the introducer sheath; therefore, the device was retracted from the introducer sheath without any issues.The concerto implant coil tip outer diameter (od) was measured to be 0.0138¿, which was found to be within specification (specification.0142¿ +.0010¿/-.0032¿).The introducer sheath id (inner diameter) was measured to be.020¿ (0.50mm), which was found to be within specification (specification 0.47mm +0.05m/-0.00mm).No further testing was carried out with an in-house microcatheter due to the damaged condition of the concerto coils.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the damage found with the returned concerto coil is consistent with resistance.A few possible causes of ¿coil resistance/stuck in catheter¿ are but not limited to damage or kink to pushwire, and tortuous anatomy.The root cause was unable to be determined.The reported merits taper microcatheter (non-medtronic device) was not returned; therefore, any contribution the microcatheter had towards the resistance was unable to be verified.The concerto implant coils were found to be compatible with the mertis microcatheter.The customer¿s report of ¿coil resistance/stuck in sheath¿ was able to be confirmed.During testing the implant coil failed to advance outside of the introducer sheath.A possible cause of ¿coil resistance/stuck in sheath¿ could be that the introducer sheath was found inverted on the pusher.It is likely that resistance would occur when attempting to push the implant coil out from this portion of the introducer sheath as this portion of the introducer sheath is designed to create resistance with the pushwire portion of the concerto coil.It is likely that the customer inadvertently inverted the concerto coil fo llowing hydration or during inspection.The cause was unable to be confirmed.A few other possible causes of ¿coil resistance/stuck in sheath¿ are but not limited to damage during preparation and overtightening of rhv.Customer reported vessel tortuosity as moderate, with the blood flow noted to be normal.The devices were reported to be prepared per ifu.The customer¿s report of ¿pushwire kink/damage¿ was able to be confirmed as the concerto device (lot- d036397) was returned with damage to the pushwire.The concerto device was returned with the pushwire bent/kinked, and the implant coil was damaged.During the procedure the first concerto device met resistance within the microcatheter body and proximal damage was noticed to the pushwire.This was unable to be confirmed as the damage found to the pushwire was in the middle segment.The likely cause of the ¿pusher kink/damage¿ was found to be advancing the concerto devices against the reported resistance.The customer¿s report of ¿premature detachment¿ and ¿coil separation¿ were unable to be confirmed.The implant coil was found to be unbroken and still attached to the pushwire detach element.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.For coils pv-20-50-helix, lot d036397, the introducer sheath was held horizontally during hydration when the implant coil was pulled back inside.For coil pv-18-40-helix, lot d012376, it was reported that prior to the non-detachment event, no issues were encountered, and the detacher did not show any visual problems.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22577731
• Report Number: 2029214-2025-01668
• Device Sequence Number: 13121411
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: (01)00847536045064(17)280326(10)D036397
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: D036397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/21/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female